Jazz Pharmaceuticals Inc., a specialty pharmaceutical company focused on identifying, developing and commercialising innovative products to meet unmet medical needs in neurology and psychiatry, received an approvable letter from US FDA for its once-a-day Luvox CR (fluvoxamine maleate) extended-release capsules.
For Luvox CR (fluvoxamine maleate) extended-release capsules Jazz and Solvay are seeking marketing approval for the treatment of two anxiety disorders - social anxiety disorder (SDA) and obsessive compulsive disorder (OCD), according to the company sources
However, FDA has requested information related to the companies' response concerning the previously disclosed CMC issue. The companies are seeking clarification from FDA and look forward to working with FDA to resolve this as quickly as possible.
The approvable letter did not raise any questions related to safety or efficacy of Luvox CR. The approvable letter included the FDA's proposed labelling.
The FDA approved Luvox (fluvoxamine maleate) for the treatment of OCD on December 20, 2007.
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